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Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19 (OPTIMIST)

200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to SARS-CoV-2.

The study consists of two visits. At the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study.

At the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing.

The aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection COVID-19. Clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to CT data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.

研究概览

研究类型

观察性的

注册 (预期的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Moscow、俄罗斯联邦、129226
        • 招聘中
        • Russian Clinical Research Center for Gerontology
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Men and women aged 18 and over with asymptomatic or severe course of the novel coronavirus infection COVID-19, or who have been in close contact with patients with confirmed coronavirus infection, but who are not sick and do not have antibodies to SARS-CoV-2

描述

Inclusion Criteria:

For all groups:

  • Informed consent signed by the patient.
  • Men and women aged 18 and over.

Group COVID-19 (asymptomatic):

  • Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
  • Absence of any clinical symptoms associated with coronavirus infection.

Group Healthy:

  • Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
  • Absence of any clinical symptoms associated with coronavirus infection

Group COVID symptomatic:

  • Confirmed diagnosis of previous COVID-19 (positive SARS-CoV-2 RNA PCR test or presence of IgM antibodies to SARS-CoV-2) in history.
  • A severe course of COVID-19, characterized by one or more of the following symptoms:

    • Respiratory rate ≥ 30 in 1 min
    • Blood oxygen saturation (SpO2) ≤ 93%
    • The ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (PaO2 / FiO2) <300
    • Lung tissue lesion> 50% and / or according to computed tomography CT-2 and higher
    • Septic shock / sepsis
    • Development of multiple organ failure
    • Cytokine storm

Exclusion Criteria:

  • Pregnancy
  • Covid-19 vaccination
  • Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
  • Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
  • Refusal to participate in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Patients with severe COVID-19 pneumonia
All patients will undergo a comprehensive examination to identify the consequences of COVID-19
Patients who had an asymptomatic COVID-19 3 months ago
All patients will undergo a comprehensive examination to identify the consequences of COVID-19
People who had close contact with patients with confirmed COVID-19 3 months ago but did not get sick
All patients will undergo a comprehensive examination to identify the consequences of COVID-19

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The presense of postcovid syndrome
大体时间:through study completion, an average of 3 months
Clinical and laboratory indicators The number and severity of signs of postcovid syndrome
through study completion, an average of 3 months

次要结果测量

结果测量
措施说明
大体时间
Pathological changes in lung tissue according to CT data
大体时间:through study completion, an average of 3 months
CT scan
through study completion, an average of 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月20日

初级完成 (预期的)

2021年5月15日

研究完成 (预期的)

2021年6月15日

研究注册日期

首次提交

2021年3月21日

首先提交符合 QC 标准的

2021年5月1日

首次发布 (实际的)

2021年5月4日

研究记录更新

最后更新发布 (实际的)

2021年5月4日

上次提交的符合 QC 标准的更新

2021年5月1日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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